Three Chemo Regimens as an Adjunct to ART for Treatment of Advanced AIDS-KS

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Beginning on day one of the chemotherapy cycle, ET will be given orally in a dose of 50 mg twice daily for 7 consecutive days for the first cycle. If there is no Grade ≥ 2 toxicity attributable to ET after the first cycle, the dose will be escalated to 150 mg daily for 7 days in divided doses of 100 mg/50 mg for the second cycle. After the second cycle, if there is no Grade ≥ 2 toxicity attributable to ET, the dose will be escalated to 100 mg twice daily for 7 days for the third and subsequent cycles.

Treatment with ET will continue for six cycles at the maximum dose achieved or until toxicity requiring discontinuation of study chemotherapy, or the site investigator, after consulting with the A5263/AMC 066 CMC, has determined that alternative therapy is required, whichever occurs first.

Vincristine sulfate will be administered at a dose of 2 mg (fixed dose) in a volume of 2 mL over 1 minute into the sidearm of a rapidly flowing intravenous infusion every 3 weeks. The vincristine infusion will be followed by bleomycin as detailed below.

Bleomycin sulfate will be administered at a dose of 15 units/m2 over 10 minutes every 3 weeks.

Treatment with BV will continue for six cycles, or until toxicity requiring discontinuation of study chemotherapy, or the site investigator, after consulting with the A5263/AMC 066 CMC, has determined that alternative therapy is required, whichever occurs first.

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria for Step 1:

HIV-1 infection

Biopsy diagnostic of KS at any time prior to study entry.

Current KS stage T1 using ACTG criteria.

A minimum of five indicator KS cutaneous marker lesions plus an additional two lesions greater or equal to 4x4 mm that are accessible for punch biopsy.

CD4+ lymphocyte cell count obtained within 28 days prior to study entry at a DAIDS-approved laboratory.

Certain laboratory values, as defined in the protocol, obtained within 14 days prior to study entry.

Cardiac ejection fraction of greater than or equal to 50% obtained within 14 days prior to study entry.

Female study volunteers of reproductive potential must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL performed within 24 hours before initiating the protocol-specified medications.

All participants must agree not to participate in a conception process (active attempt to become pregnant or to impregnate, donate sperm, in vitro fertilization).

If participating in sexual activity that could lead to pregnancy, participant must agree that two reliable forms of contraceptives will be used simultaneously while receiving protocol-specified medications, and for 6 weeks after stopping the medications. Study volunteers who are not of reproductive potential (women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy and/or bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraceptives.

Ability to swallow oral medications and adequate venous access.

Karnofsky performance status ≥ 60 within 28 days prior to entry.

Ability and willingness of participant or legal guardian/representative to provide informed consent.

Exclusion Criteria for Step 1:

Current chronic, acute, or recurrent serious infections for which the participant has not completed at least 14 days of therapy prior to Step 2 entry and/or is not clinically stable.

Current or history of known pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), emphysema, bronchiectasis, or diffuse or significant local radiographic interstitial infiltrates on chest x-ray (CXR) or computed axial tomography (CAT).

Oxygen saturation less than 90% and/or exercise desaturation greater than 4% within 14 days prior to study enrollment.

Grade ≥3 peripheral neuropathy (PN) at entry.

Breastfeeding.

Receipt of ART for more than 28 days immediately prior to entry.

Prior or current systemic or locally administered chemotherapy.

Prior or current radiation therapy.

Prior or current immunotherapy, e.g., interferon alfa.

Corticosteroid use at doses above those given as replacement therapy for adrenal insufficiency within the last 30 days prior to study entry.

Any immunomodulator, HIV vaccine, live attenuated vaccines, or other investigational therapy or investigational vaccine within 30 days prior to study entry.

Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.

Active drug or alcohol use or dependence that would interfere with adherence to study requirements.

Current or anticipated receipt of any of the prohibited medications listed in section 5.5.2 of the protocol.

In the opinion of the investigator, any psychological or social condition, or addictive disorder that would preclude compliance with the protocol.